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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ureteroscope and accessories, flexible/rigid
Regulation Description Endoscope and accessories.
Definition To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeFGB
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 1
OTU MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K181977  WiScope Digital Endoscope System
  2.  K210579  WiScope OM Endoscope System, WiScope Single-Use Di ...
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 35 35
2017 142 142
2018 118 118
2019 207 207
2020 402 402
2021 269 269

Device Problems MDRs with this Device Problem Events in those MDRs
Break 409 409
Microbial Contamination of Device 143 143
Adverse Event Without Identified Device or Use Problem 112 112
No Display/Image 69 69
Poor Quality Image 48 48
Material Protrusion/Extrusion 47 47
Fluid Leak 40 40
Mechanical Problem 34 34
Appropriate Term/Code Not Available 29 29
Device Reprocessing Problem 28 28
Leak/Splash 28 28
Material Puncture/Hole 18 18
Device Contamination with Chemical or Other Material 17 17
Material Deformation 17 17
Difficult to Remove 14 14
Defective Device 12 12
Fracture 11 11
Material Split, Cut or Torn 10 10
Mechanical Jam 10 10
Material Separation 10 10
Material Fragmentation 9 9
Physical Resistance/Sticking 9 9
Material Perforation 9 9
Crack 9 9
Contamination /Decontamination Problem 9 9
Material Twisted/Bent 9 9
Device Operates Differently Than Expected 8 8
Tear, Rip or Hole in Device Packaging 8 8
Insufficient Information 8 8
Device Damaged Prior to Use 8 8
Detachment Of Device Component 7 7
Device Handling Problem 7 7
Use of Device Problem 7 7
Device Displays Incorrect Message 6 6
Defective Component 6 6
Display or Visual Feedback Problem 6 6
No Device Output 6 6
Entrapment of Device 5 5
Kinked 5 5
Failure to Power Up 5 5
Peeled/Delaminated 5 5
Optical Problem 5 5
Unintended Movement 5 5
Contamination 5 5
Bent 5 5
Problem with Sterilization 4 4
Display Difficult to Read 4 4
Improper Device Output 4 4
Material Frayed 4 4
Component Missing 4 4
Device Damaged by Another Device 4 4
Erratic or Intermittent Display 4 4
Cut In Material 4 4
Detachment of Device or Device Component 3 3
Material Too Rigid or Stiff 3 3
False Device Output 3 3
Hole In Material 3 3
Unsealed Device Packaging 3 3
Image Display Error/Artifact 3 3
Degraded 3 3
Melted 3 3
Retraction Problem 3 3
Device Dislodged or Dislocated 3 3
Therapeutic or Diagnostic Output Failure 2 2
Connection Problem 2 2
Material Integrity Problem 2 2
Power Problem 2 2
Corroded 2 2
Fitting Problem 2 2
Dent in Material 2 2
Failure to Clean Adequately 2 2
Device Contamination With Biological Material 2 2
Loss of Power 2 2
Unexpected Shutdown 2 2
Blocked Connection 2 2
Labelling, Instructions for Use or Training Problem 2 2
Positioning Problem 2 2
Loose or Intermittent Connection 2 2
Difficult to Advance 2 2
Thermal Decomposition of Device 2 2
Component Falling 1 1
Material Distortion 1 1
Material Rupture 1 1
Sharp Edges 1 1
Difficult To Position 1 1
Stretched 1 1
Nonstandard Device 1 1
Output Problem 1 1
Out-Of-Box Failure 1 1
Positioning Failure 1 1
Partial Blockage 1 1
Device Contaminated During Manufacture or Shipping 1 1
Aspiration Issue 1 1
Sticking 1 1
Device Maintenance Issue 1 1
Failure to Capture 1 1
Image Resolution Poor 1 1
Product Quality Problem 1 1
Unstable 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 368 368
No Known Impact Or Consequence To Patient 246 246
No Clinical Signs, Symptoms or Conditions 210 210
No Patient Involvement 149 149
Injury 48 48
Unspecified Infection 41 41
Fever 26 26
No Code Available 14 14
Perforation 13 13
Foreign Body In Patient 12 12
Insufficient Information 11 11
Bacterial Infection 11 11
Laceration(s) 6 6
Device Embedded In Tissue or Plaque 6 6
No Information 5 5
Patient Problem/Medical Problem 5 5
Inflammation 5 5
Tissue Damage 5 5
Physical Entrapment 3 3
Hematuria 2 2
Urinary Tract Infection 2 2
Hemorrhage/Bleeding 2 2
Death 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Kidney or Urinary Problem 2 2
Unspecified Blood or Lymphatic problem 1 1
Urethral Stenosis/Stricture 1 1
Edema 1 1
Hematoma 1 1
Abdominal Pain 1 1
Nausea 1 1
Internal Organ Perforation 1 1
Pain 1 1
Renal Failure 1 1
Sepsis 1 1
Septic Shock 1 1
Tachycardia 1 1
Uterine Perforation 1 1
Vomiting 1 1
Rupture 1 1
Excessive Tear Production 1 1
Stenosis 1 1
Blood Loss 1 1
Intraoperative Pain 1 1
Complaint, Ill-Defined 1 1
Increased Respiratory Rate 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Jul-20-2018
2 Pentax Medical Company II Jun-28-2016
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